AS/NZS 3200.2.4:1993
Approval and test specification - Medical electrical equipment - Particular requirements for safety - Cardiac defibrillators and cardiac defibrillator-monitors
Specifies the particular safety requirements for the safety of cardiac defibrillators and cardiac defibrillator-monitors. It does not apply to a cardiac monitor which is not part of a cardiac defibrillator-monitor and for combined equipment where the EGG monitoring signal cannot be derived via the Defibrillator electrodes this standard applies to the defibrillator only. It is supplementary to AS 3200.1-1990/NZS 6150:1990 Approval and test specification - Medical electrical equipment, Part 1: General requirements for safety, and is technically equivalent to IEC 60601-2-4:1983.
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AS/NZS 3200.2.4:1993 MEDICAL ELECTRICAL EQUIPMENT-APPROVAL AND TEST SPECIFICATION - PARTICULAR REQUIREMENT FOR SAFETY-CARDIAC...
PREFACE
CONTENTS
SECTION ONE - GENERAL
1. Scope and object
2. Terminology and definitions
3. General requirements
4. General requirements for tests
5. Classification
6. Identification, marking and documents
7. Power input
SECTION TWO - SAFETY REQUIREMENTS
SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
13. General
14. Requirements related to classification
17. Insulation and PROTECTIVE IMPEDANCES
18. Earthing and potential equalization
19. Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
20. Dielectric strength
SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
SECTION SIX - PROTECTION AGAINST THE HAZARDS OF EXPLOSIONS IN MEDICALLY USED ROOMS
SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES, FIRE AND OTHER HAZARDS, SUCH AS HUMAN ERRORS
42. Excessive temperatures
43. Fire prevention
44. Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection
45. Pressure vessels and parts subject to pressure
46. Human errors
SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION AGAINST INCORRECT OUTPUT
50. Accuracy of operating data
51. Protection against incorrect output
SECTION NINE - FAULT CONDITIONS CAUSING OVERHEATING AND/OR MECHANICAL DAMAGE; ENVIRONMENTAL TESTS
SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
56. Components and general assembly
57. MAINS PARTS, components and layout
SECTION 101 - ADDITIONAL REQUIREMENTS RELATING TO SAFETY
101. Charging time
102. INTERNAL ELECTRICAL POWER SOURCE
103. Endurance
104. SYNCHRONIZER
105. Recovery of the CARDIAC MONITOR after defibrillation
106. Disturbance to the CARDIAC MONITOR from charging or internal discharging
APPENDIX B TESTING DURING MANUFACTURE AND/OR INSTALLATION
APPENDIX AA - RATIONALE
APPENDIX ZZ - AMENDMENTS TO IEC 601-2-4 FOR APPLICATION IN AUSTRALIA AND NEW ZEALAND
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AS/NZS 3200.2.4:1993 MEDICAL ELECTRICAL EQUIPMENT-APPROVAL AND TEST SPECIFICATION - PARTICULAR REQUIREMENT FOR SAFETY-CARDIAC...
PREFACE
CONTENTS
SECTION ONE - GENERAL
1. Scope and object
2. Terminology and definitions
3. General requirements
4. General requirements for tests
5. Classification
6. Identification, marking and documents
7. Power input
SECTION TWO - SAFETY REQUIREMENTS
SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
13. General
14. Requirements related to classification
17. Insulation and PROTECTIVE IMPEDANCES
18. Earthing and potential equalization
19. Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
20. Dielectric strength
SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
SECTION SIX - PROTECTION AGAINST THE HAZARDS OF EXPLOSIONS IN MEDICALLY USED ROOMS
SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES, FIRE AND OTHER HAZARDS, SUCH AS HUMAN ERRORS
42. Excessive temperatures
43. Fire prevention
44. Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection
45. Pressure vessels and parts subject to pressure
46. Human errors
SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION AGAINST INCORRECT OUTPUT
50. Accuracy of operating data
51. Protection against incorrect output
SECTION NINE - FAULT CONDITIONS CAUSING OVERHEATING AND/OR MECHANICAL DAMAGE; ENVIRONMENTAL TESTS
SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
56. Components and general assembly
57. MAINS PARTS, components and layout
SECTION 101 - ADDITIONAL REQUIREMENTS RELATING TO SAFETY
101. Charging time
102. INTERNAL ELECTRICAL POWER SOURCE
103. Endurance
104. SYNCHRONIZER
105. Recovery of the CARDIAC MONITOR after defibrillation
106. Disturbance to the CARDIAC MONITOR from charging or internal discharging
APPENDIX B TESTING DURING MANUFACTURE AND/OR INSTALLATION
APPENDIX AA - RATIONALE
APPENDIX ZZ - AMENDMENTS TO IEC 601-2-4 FOR APPLICATION IN AUSTRALIA AND NEW ZEALAND
AS/NZS 3200.2.4:1993
Online Library subscription information
Online library subscriptions provide a cost-effective solution for organisations of any size to access the latest standards, offering 24/7 access to a personalised catalogue. The service ensures subscribers have have the most up-to-date version of selected standards, incluing automatic updates for any amendments or versions. Pricing is dependent on the chosen standards and the number of concurrent users, with discounts applied from the standards PDF price. For customised subscriptions or further inquiries, contact the Online Library team.